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Are you looking for more information on Niktimvo™ (axatilimab-csfr)?

Register today by filling out the form below. Sign up to stay connected with the chronic graft-versus-host disease (GVHD) community and to receive more information about Niktimvo.

Consent for Use of Personal Information

By clicking “Sign Up” below, I certify that I am 18 years of age or older and authorize Incyte Corporation (“Incyte”) and its agents to use my registration information provided above (my “information”) to contact me in order to provide education and ongoing support services related to product, disease and other areas of interest. I understand that I may at any time revoke my consent to be contacted for any of these purposes by opting out from future communications from Incyte. I also understand that the information I provide may be combined with that of other registrants to create aggregated, anonymized data and to use and share only the anonymized data for any legitimate business purpose. Learn more about how Incyte processes your personal information at Privacy Policy.

U.S. State Law Consent to Health Data Use for Patient Support Programs

I consent to Incyte collecting, using and disclosing my health data for the following purposes:

  • To enroll me and manage my participation in Incyte’s GVHD CRM Program, which includes activities related to my condition or treatment (for example, co-pay card programs, payer medication coverage verification, nurse educator support, disease management support), and to manage Incyte’s products, services, and programs related to my condition or treatment.

Incyte uses the following when it administers the Incyte GVHD CRM Program:

  • Health data – my name (and the name of my caregiver if applicable), gender, date of birth, contact information and information relating to my health condition or treatment.

I understand that my consent to this use of my health data is required for me to participate in the Incyte GVHD CRM Program. I also understand that Incyte will not sell my health data to third parties, but Incyte may disclose my health data to Incyte’s vendors only for Incyte’s business purposes related to the Incyte GVHD CRM Program. I understand that Incyte may use my health data to contact me by email, for the above purposes. I also understand that if I do not consent to the use of my health data for the above purposes, I will not be able to participate in the program. Finally, I understand that I may withdraw my consent to processing my health data for the above purposes at any time by calling 1-855-446-2983 or visiting https://www.incyte.com/privacy-policy and that if I withdraw my consent, I will no longer be able to participate in the program. I understand that this consent will remain in effect for one year.

By signing above, I am indicating that I am legally authorized to consent and that I am providing my consent as the patient or the patient’s legal guardian for Incyte to collect, process and disclose my health data I provide for the purposes described within the Consent above.

Indications and Usage

NiktimvoTM (axatilimab-csfr) is a prescription medicine used to treat adults and children who weigh at least 88.2 pounds (40 kg) with chronic graft-versus-host disease (cGVHD) after receiving at least 2 prior treatments (systemic therapy) and they did not work.

It is not known if Niktimvo is safe and effective in adults and children weighing less than 88.2 pounds (40 kg).

IMPORTANT SAFETY INFORMATION

What are the possible side effects of Niktimvo?

Niktimvo may cause serious side effects, including:

Infusion-related reactions. Infusion-related reactions are common with Niktimvo and can be serious. Your healthcare provider will monitor you for infusion-related reactions during your treatment. If you have a reaction, your healthcare provider may temporarily or completely stop your treatment with Niktimvo. Tell your healthcare provider right away if you have fever, chills, rash, flushing, shortness of breath, trouble breathing, nausea, vomiting, or symptoms of high blood pressure such as chest pain, headaches, or blurred vision during an infusion of Niktimvo.

The most common side effects of Niktimvo include:

  • infections
  • increased blood level of liver enzymes
  • decreased blood level of phosphate
  • low red blood cell count (anemia)
  • muscle, bone, or joint pain
  • increased blood level of pancreatic enzymes
  • low energy
  • increased blood level of calcium
  • increased blood level of a muscle enzyme
  • increased blood level of a bone enzyme
  • nausea
  • headache
  • diarrhea
  • cough
  • fever
  • shortness of breath

These are not all the possible side effects of Niktimvo. Call your doctor for medical advice about side effects.

Before receiving Niktimvo, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had liver problems.
  • are pregnant or plan to become pregnant. Niktimvo may harm your unborn baby.

    Females who are able to become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with Niktimvo.
    • You should use an effective method of birth control during your treatment and for 30 days after your last dose of Niktimvo. Talk to your healthcare provider about birth control methods that you can use during this time.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Niktimvo.
  • are breastfeeding or plan to breastfeed. It is not known if Niktimvo passes into your breast milk. Do not breastfeed during treatment and for 30 days after your last dose of Niktimvo.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the Full Prescribing Information, which includes a more complete discussion of the risks associated with Niktimvo.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You may also report side effects to Incyte Medical Information at 1-855-463-3463.

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Indications and Usage

NiktimvoTM (axatilimab-csfr) is a prescription medicine used to treat adults and children who weigh at least 88.2 pounds (40 kg) with chronic graft-versus-host disease (cGVHD) after receiving at least 2 prior treatments (systemic therapy) and they did not work.

It is not known if Niktimvo is safe and effective in adults and children weighing less than 88.2 pounds (40 kg).

IMPORTANT SAFETY INFORMATION

What are the possible side effects of Niktimvo?

Niktimvo may cause serious side effects, including:

Infusion-related reactions. Infusion-related reactions are common with Niktimvo and can be serious. Your healthcare provider will monitor you for infusion-related reactions during your treatment. If you have a reaction, your healthcare provider may temporarily or completely stop your treatment with Niktimvo. Tell your healthcare provider right away if you have fever, chills, rash, flushing, shortness of breath, trouble breathing, nausea, vomiting, or symptoms of high blood pressure such as chest pain, headaches, or blurred vision during an infusion of Niktimvo.

The most common side effects of Niktimvo include:

  • infections
  • increased blood level of liver enzymes
  • decreased blood level of phosphate
  • low red blood cell count (anemia)
  • muscle, bone, or joint pain
  • increased blood level of pancreatic enzymes
  • low energy
  • increased blood level of calcium
  • increased blood level of a muscle enzyme
  • increased blood level of a bone enzyme
  • nausea
  • headache
  • diarrhea
  • cough
  • fever
  • shortness of breath

These are not all the possible side effects of Niktimvo. Call your doctor for medical advice about side effects.

Before receiving Niktimvo, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had liver problems.
  • are pregnant or plan to become pregnant. Niktimvo may harm your unborn baby.

    Females who are able to become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with Niktimvo.
    • You should use an effective method of birth control during your treatment and for 30 days after your last dose of Niktimvo. Talk to your healthcare provider about birth control methods that you can use during this time.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Niktimvo.
  • are breastfeeding or plan to breastfeed. It is not known if Niktimvo passes into your breast milk. Do not breastfeed during treatment and for 30 days after your last dose of Niktimvo.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the Full Prescribing Information, which includes a more complete discussion of the risks associated with Niktimvo.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You may also report side effects to Incyte Medical Information at 1-855-463-3463.